Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

March 25, 2026 updated by: SWOG Cancer Research Network

A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm.

SECONDARY OBJECTIVES:

I. To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined biochemical leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed.

II. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo.

III. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30-(C30), in participants randomized to receive preoperative lanreotide versus placebo.

ADDITIONAL OBJECTIVES:

I. To compare change from baseline in pancreatic cancer-specific quality of life and overall health-related quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ- Pancreatic Cancer 26 (PAN26) and European Quality of Life Five Dimension Five Level (EQ-5D-5L), in participants randomized to receive preoperative lanreotide versus placebo.

II. To compare the proportions of participants with common postoperative sequelae associated with POPF, including ISGPS delayed gastric emptying and ISGPS post pancreatectomy hemorrhage (grades B/C) occurring within 60 days after surgery, in participants randomized to receive preoperative lanreotide versus placebo.

III. To compare time from surgery to initiation of adjuvant chemotherapy among participants with pancreatic ductal adenocarcinoma and planned adjuvant chemotherapy randomized to receive preoperative lanreotide versus placebo.

BANKING OBJECTIVE:

I. To bank blood, pancreas fluid, and tissue specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lanreotide subcutaneously (SC) over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.

ARM II: Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.

After completion of study treatment, patients are followed up at 4, 8 and 12 months after surgery.

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Suspended
        • University of Alabama at Birmingham Cancer Center
      • Daphne, Alabama, United States, 36526
        • Suspended
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
      • Fairhope, Alabama, United States, 36532
        • Suspended
        • Thomas Hospital
      • Mobile, Alabama, United States, 36607
        • Suspended
        • Mobile Infirmary Medical Center
      • Saraland, Alabama, United States, 36571
        • Suspended
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Suspended
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Suspended
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew M. Lowy
      • Loma Linda, California, United States, 92357
        • Suspended
        • Veterans Affairs Loma Linda Healthcare System
      • Los Angeles, California, United States, 90033
        • Suspended
        • USC / Norris Comprehensive Cancer Center
      • San Diego, California, United States, 92103
        • Suspended
        • UC San Diego Medical Center - Hillcrest
    • Delaware
      • Newark, Delaware, United States, 19718
        • Suspended
        • Christiana Care Health System-Christiana Hospital
      • Newark, Delaware, United States, 19713
        • Suspended
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Suspended
        • Medical Oncology Hematology Consultants PA
      • Wilmington, Delaware, United States, 19801
        • Suspended
        • Christiana Care Health System-Wilmington Hospital
    • Florida
      • Ruskin, Florida, United States, 33570
        • Suspended
        • Moffitt Cancer Center at SouthShore
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Contact:
        • Principal Investigator:
          • Andrew J. Sinnamon
      • Tampa, Florida, United States, 33607
        • Suspended
        • Moffitt Cancer Center-International Plaza
      • Tampa, Florida, United States, 33612
        • Suspended
        • Moffitt Cancer Center
      • Wesley Chapel, Florida, United States, 33544
        • Suspended
        • Moffitt Cancer Center at Wesley Chapel
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Suspended
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30308
        • Suspended
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Suspended
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30303
        • Suspended
        • Grady Health System
      • Johns Creek, Georgia, United States, 30097
        • Suspended
        • Emory Johns Creek Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Akhil Chawla
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Aslam Ejaz
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
      • Geneva, Illinois, United States, 60134
        • Suspended
        • Northwestern Medicine Cancer Center Delnor
      • Oak Brook, Illinois, United States, 60523
        • Suspended
        • Northwestern Medicine Oak Brook
      • Orland Park, Illinois, United States, 60462
        • Suspended
        • Northwestern Medicine Orland Park
      • Warrenville, Illinois, United States, 60555
        • Suspended
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Suspended
        • Indiana University/Melvin and Bren Simon Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Michael J. Cavnar
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Suspended
        • University Medical Center New Orleans
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Suspended
        • Christiana Care - Union Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Suspended
        • University of Michigan Rogel Cancer Center
      • Battle Creek, Michigan, United States, 49017
        • Suspended
        • Bronson Battle Creek
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Muskegon, Michigan, United States, 49444
        • Suspended
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, United States, 49120
        • Suspended
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Suspended
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, United States, 49677
        • Suspended
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Suspended
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Suspended
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Wyoming, Michigan, United States, 49519
        • Suspended
        • University of Michigan Health - West
    • Minnesota
      • Aitkin, Minnesota, United States, 56431
        • Suspended
        • Riverwood Healthcare Center
      • Baxter, Minnesota, United States, 56425
        • Suspended
        • Essentia Health - Baxter Clinic
      • Brainerd, Minnesota, United States, 56401
        • Suspended
        • Essentia Health Saint Joseph's Medical Center
      • Crosslake, Minnesota, United States, 56442
        • Suspended
        • Essentia Health - Saint Joseph's Crosslake Clinic
      • Deer River, Minnesota, United States, 56636
        • Suspended
        • Essentia Health - Deer River Clinic
      • Detroit Lakes, Minnesota, United States, 56501
        • Suspended
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth, Minnesota, United States, 55805
        • Suspended
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Suspended
        • Miller-Dwan Hospital
      • Duluth, Minnesota, United States, 55805
        • Suspended
        • Essentia Health Cancer Center
      • Ely, Minnesota, United States, 55731
        • Suspended
        • Essentia Health - Ely Clinic
      • Fosston, Minnesota, United States, 56542
        • Suspended
        • Essentia Health - Fosston
      • Hibbing, Minnesota, United States, 55746
        • Suspended
        • Essentia Health Hibbing Clinic
      • International Falls, Minnesota, United States, 56649
        • Suspended
        • Essentia Health - International Falls Clinic
      • Moose Lake, Minnesota, United States, 55767
        • Suspended
        • Essentia Health - Moose Lake Clinic
      • Park Rapids, Minnesota, United States, 56470
        • Suspended
        • Essentia Health - Park Rapids
      • Pequot Lakes, Minnesota, United States, 56472
        • Suspended
        • Essentia Health - Saint Joseph's Pequot Lakes Clinic
      • Pine River, Minnesota, United States, 56474
        • Suspended
        • Essentia Health - Saint Joseph's Pine River Clinic
      • Sandstone, Minnesota, United States, 55072
        • Suspended
        • Essentia Health Sandstone
      • Staples, Minnesota, United States, 56479
        • Suspended
        • Essentia Health - Saint Joseph's Staples Clinic
      • Virginia, Minnesota, United States, 55792
        • Suspended
        • Essentia Health Virginia Clinic
    • Missouri
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Suspended
        • University of Nebraska Medical Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Suspended
        • Renown Regional Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Suspended
        • Saint Barnabas Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Suspended
        • Rutgers Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Suspended
        • University of New Mexico Cancer Center
    • New York
      • Rochester, New York, United States, 14642
        • Suspended
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • Suspended
        • State University of New York Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Suspended
        • Carolinas Medical Center/Levine Cancer Institute
      • Concord, North Carolina, United States, 28025
        • Suspended
        • Atrium Health Cabarrus/LCI-Concord
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Suspended
        • Essentia Health Cancer Center-South University Clinic
      • Fargo, North Dakota, United States, 58122
        • Suspended
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Suspended
        • Sanford Broadway Medical Center
      • Jamestown, North Dakota, United States, 58401
        • Suspended
        • Essentia Health - Jamestown Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Suspended
        • University of Cincinnati Cancer Center-UC Medical Center
      • Columbus, Ohio, United States, 43210
        • Suspended
        • Ohio State University Comprehensive Cancer Center
      • West Chester, Ohio, United States, 45069
        • Suspended
        • University of Cincinnati Cancer Center-West Chester
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Saint Luke's Cancer Center - Allentown
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • Darius C. Desai
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 484-503-4151
        • Principal Investigator:
          • Darius C. Desai
      • Chadds Ford, Pennsylvania, United States, 19317
        • Suspended
        • Christiana Care Health System-Concord Health Center
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • Saint Luke's Hospital-Anderson Campus
        • Contact:
        • Principal Investigator:
          • Darius C. Desai
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • Saint Luke's Hospital - Upper Bucks Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • Darius C. Desai
      • Stroudsburg, Pennsylvania, United States, 18360
        • Recruiting
        • Saint Luke's Hospital - Monroe Campus
        • Contact:
        • Principal Investigator:
          • Darius C. Desai
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Suspended
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Suspended
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Suspended
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Suspended
        • University of Tennessee - Knoxville
      • Memphis, Tennessee, United States, 38120
        • Suspended
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Suspended
        • University of Vermont and State Agricultural College
      • Burlington, Vermont, United States, 05401
        • Suspended
        • University of Vermont Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Leopoldo J. Fernandez
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Leopoldo J. Fernandez
        • Contact:
      • Roanoke, Virginia, United States, 24033
        • Suspended
        • Carilion Roanoke Memorial Hospital
      • Winchester, Virginia, United States, 22601
        • Suspended
        • Valley Health / Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Suspended
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, United States, 98109
        • Suspended
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Suspended
        • Northwest Wisconsin Cancer Center
      • Ashland, Wisconsin, United States, 54806
        • Suspended
        • Duluth Clinic Ashland
      • Hayward, Wisconsin, United States, 54843
        • Suspended
        • Essentia Health-Hayward Clinic
      • Hayward, Wisconsin, United States, 54843
        • Suspended
        • Tamarack Health Hayward Medical Center
      • Marshfield, Wisconsin, United States, 54449
      • Mukwonago, Wisconsin, United States, 53149
        • Suspended
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, United States, 53066
        • Suspended
        • ProHealth Oconomowoc Memorial Hospital
      • Spooner, Wisconsin, United States, 54801
        • Suspended
        • Essentia Health-Spooner Clinic
      • Superior, Wisconsin, United States, 54880
        • Suspended
        • Essentia Health Saint Mary's Hospital - Superior
      • Waukesha, Wisconsin, United States, 53188
        • Suspended
        • ProHealth Waukesha Memorial Hospital
      • Waukesha, Wisconsin, United States, 53188
        • Suspended
        • UW Cancer Center at ProHealth Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
  • Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
  • Participants must not have a known history of a prior diagnosis of malabsorption syndrome
  • Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
  • Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization
  • Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization
  • Participants must be ≥ 18 years old
  • Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization
  • Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization

  • Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:

    • Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed
    • Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels
    • Bromocriptine: Dose adjustments may be considered to account for absorption changes
    • Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary
    • CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure

  • In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy

    • NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible
  • In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation
  • Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase [AST] > 190 U/L or alanine aminotransferase [ALT] > 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped)
  • Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must be offered the opportunity to participate in specimen banking
  • Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study
  • NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (lanreotide, distal pancreatectomy)
Patients receive lanreotide SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Other: Questionnaire Administration
Ancillary studies
Procedure: Distal Pancreatectomy
Undergo distal pancreatectomy
Procedure: Biospecimen Collection
Undergo blood sample and pancreas fluid collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Lanreotide
Given SC
Other Names:
  • Ipstyl
  • Somatuline
  • Angiopeptin
  • BIM-23014
  • DC 13116
  • Dermopeptin
  • Somatulina
Placebo Comparator: Arm II (saline placebo, distal pancreatectomy)
Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
Other: Questionnaire Administration
Ancillary studies
Other: Saline
Given SC
Other Names:
  • Sodium Chloride 0.9%
  • Normal Saline
  • ISOTONIC SODIUM CHLORIDE SOLUTION
Procedure: Distal Pancreatectomy
Undergo distal pancreatectomy
Procedure: Biospecimen Collection
Undergo blood sample and pancreas fluid collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative pancreatic fistula (POPF)
Time Frame: Up to 60 days after distal pancreatectomy
POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.
Up to 60 days after distal pancreatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of biochemical leak (BL)
Time Frame: Up to 60 days after distal pancreatectomy
BL will be defined by the ISGPS as a peritoneal drain amylase greater than three times the upper limit of the institutional normal serum amylase without an effect on clinical management or duration of hospital stay. BL will only be measured in those who had a peritoneal drain placed. Treatment arm differences will be assessed via logistic regression model with adjustment for stratification factor.
Up to 60 days after distal pancreatectomy
Number of post-operation hospital days
Time Frame: From the time of surgery up to 60 days after distal pancreatectomy
Mean hospital length of stay will be compared according to treatment arm via linear regression model with adjustment for stratification factor.
From the time of surgery up to 60 days after distal pancreatectomy
Change in overall quality of life (QOL)
Time Frame: At baseline and at 14 and 60 days after surgery
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Core 30 (C30). Treatment arm differences in EORTC QLQ-C30 changes will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
At baseline and at 14 and 60 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pancreatic specific QOL
Time Frame: At baseline and up to 60 days after distal pancreatectomy
Will be assessed using EORTC QLQ- Pancreatic Cancer 26. Treatment arm differences in changes from baseline will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
At baseline and up to 60 days after distal pancreatectomy
Change in health-related QOL
Time Frame: At baseline and up to 60 days after distal pancreatectomy
Will be assessed using the European Quality of Life Five Dimension Five Level scale. Treatment arm differences in changes from baseline will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.
At baseline and up to 60 days after distal pancreatectomy
Delayed gastric emptying (DGE)
Time Frame: Up to 60 days after distal pancreatectomy
DGE will be defined by the ISGPS as reinsertion or persistence of a nasogastric tube after postoperative day (POD) 3 or inability to tolerate solid oral intake by POD 7. Treatment arm differences in the proportion of participants with DGE will be assessed via logistic regression model with adjustment for stratification factor.
Up to 60 days after distal pancreatectomy
Incidence of grades B/C post-pancreatectomy hemorrhage (PPH)
Time Frame: Up to 60 days after distal pancreatectomy
PPH will be defined by the ISGPS as postoperative intra- or extra-luminal hemorrhage requiring transfusion of fluid or blood, intensive care unit transfer, therapeutic endoscopy, endovascular embolization, or reoperation. Treatment arm differences in the proportion of participants with PPH will be assessed via logistic regression model with adjustment for stratification factor.
Up to 60 days after distal pancreatectomy
Time to initiation of adjuvant chemotherapy
Time Frame: From date of surgery to date of first dose of adjuvant chemotherapy up to 60 days after distal pancreatectomy
Distributions of time from surgery to initiation of adjuvant chemotherapy, among participants with planned adjuvant chemotherapy, in each arm will be estimated via cumulative incidence and compared using the stratified log-rank test.
From date of surgery to date of first dose of adjuvant chemotherapy up to 60 days after distal pancreatectomy
Incidence of nausea and vomiting
Time Frame: Up to 60 days after distal pancreatectomy
Proportions of participants with any nausea/vomiting will be compared between treatment arms via Fisher's exact test.
Up to 60 days after distal pancreatectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jonathan G Sham, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2408 (CTEP)
  • UG1CA189974 (U.S. NIH Grant/Contract)
  • NCI-2024-08361 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • SWOG-S2408 (Other Identifier: DCP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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